Hi, I'm Dr. Kent Peterson again, and in this segment of the program, we're going to be talking about the role, the duties, and functions of the MRO assistant in reviewing the results of drug tests coming in from the laboratory and helping the MRO to conduct an interview, gather information, and report results to the employers. The material for this is contained in tab six of your syllabus, and what we are going to cover in this segment is first of all, the review of the custody and control form, which is done by the MRO assistant, both the negatives and what we call the non-negative results. We'll then review the interview that the MRO must offer to everyone with a non-negative result. We'll talk about the review of all of the results and about reporting results, split samples, confidentiality, release of medical information, and I'm going to finish by talking about the non-federally regulated world of drug testing because there's a lot of variations in the world where federal regulations are not the primary guideline. So those are the things that we're going to be covering in this segment. The role of the MRO in Department of Transportation Testing is that of a gatekeeper. We have the flow of information coming from many sources. Many different people are communicating with the MRO, and the MRO in turn is communicating with many others. And the role of the MRO is basically to assure the integrity of the drug testing process and to really make sure that the process is valid and works. The primary duty of the MRO is to review the custody and control form for errors because if there are fatal flaws then a result must be canceled. In fact, an MRO must notify a collector or the designated employer representative if any error in collection causes a test result to be canceled. So that would require error correction training on the part of the collector. As I said, an MRO must offer the opportunity for anyone with a non-negative result to talk with the MRO That doesn't mean that the MRO must interview everyone, but at least every donor must be offered that opportunity. And in my experience, almost everybody does choose to have an interview. The MRO must also review the results of clinical evaluations like a shy bladder evaluation or an opiate medical examination. And finally, an MRO must report certain medical information to an employer if there seems to be a safety issue in the workplace. And we'll go into each of these in more detail. I pointed out earlier in the basics presentation that the MRO receives, reviews, interviews, records findings. So we talked about the nine R's and the two I's. And now we're going to be going step-by-step through this in more detail. So we begin with the receipt of laboratory results. We know that all the results have to come from a drug testing laboratory directly to an MRO. They cannot go to a consortium or a third party administrator. And the negative results can now be sent electronically with no form having to come to the MRO. So electronic reporting is acceptable. At one time, we needed to actually get the laboratory copy of the custody and control form. Also, a laboratory may report quantitative results. You need as an MRO only one time to send a letter to each laboratory saying, please give me the quantitative results. And from that point on, they will send those to you. If a laboratory has rejected a specimen for testing, for example, if there were a fatal flaw, then the laboratory will communicate to you with a very standard set of explanatory remarks. So you're an MRO assistant. You're helping to review the negative results. And you can do the conduct of negative reviews totally and entirely by yourselves. In order to do that, you need two things. You need the laboratory report, which lets you know the drug test result. But you also need to know who was the person whose urine was being tested. To do that, you've got to have the MRO copy or the collection site copy or the employer copy, one of those copies which has the name and the contact information of the donor. So in order to complete the review of a negative, you have to have those two sources of information. And there's a very simple procedure. You can use copy two of the custody and control form. You can stamp the name of your MRO, their signature stamp, and then put your initials next to it so that in the process of going through a review, it's clear which MRO assistant was responsible for reviewing the negative. Because remember, an MRO is responsible for all the tests in the MRO's office and must personally review and sign off with a real live signature 5% of the negatives. The purpose is not to check up on MRO assistants, but it's to make sure that the MRO is actively involved in the total operation. So all the problem cases, the cases where there was a de minimis flaw that you decided did not require a statement of correction, or any situation where there is a statement of correction that has been received, those all must be included within that 5%. So any problem cases have to be reviewed by the MRO. Now, Dr. Smith talked about the fatal flaws for which there's no hope of correction. Those will always be reported by the MRO as canceled. She talked about the correctable flaws where you have the authority to contact them to contact the donor, excuse me, to contact the collector or the laboratory and have the corrections be received. Then there are the de minimis or de minimal errors which are so small that they do not require a statement of error correction, and I've listed those on the left. So it's vitally important that you are completely comfortable with knowing the minimum from the correctable from the fatal flaws. So that's pretty much it for the negative review of results which is the heart and soul of some of the best work that MRO assistants do. Now, for the non-negatives, that is the positive, adulterated, substituted, or invalids, there you actually have to get from the laboratory the laboratory copy of the custom control form and it has to have the signature of the certifying scientist. I have received on a number of occasions copies from the lab that did not have the signature on it and I have contacted the lab, given them a call. Usually it's remarkable. Within 60 seconds sometimes, my fax machine has started up and I have within two minutes gotten a signed copy of that. So laboratories do make mistakes and they will correct them and they will send you a copy with the certifying scientist's signature. You then also have to have, of course, the MRO copy so that you know who the donor is. You need to look for a donor signature and if the donor signature is missing then you'll need to contact the collection site and find out why did the donor not sign. If that was an error not to make a note in the form, the collector can give a correction. But if they simply don't know why, then you're going to end up having to cancel that result. Now in a handful of rare instances, once you have a non-negative, if the employer has received from DOT a stand-down waiver, you can immediately call the employer at the direction of your MRO and tell the DER, we have a positive. We are working on verifying that but in the interim, you can stand that person down from safety-sensitive duties and we'll get back with you as quickly as possible. DOT thought hundreds of employers would apply for that but only a handful of waivers have been granted. So have you ever dealt with a stand-down waiver? I certainly have not run into that in my MRO career. And then it's time to contact the donor because for every donor with a non-negative, it's the duty of the MRO's office to make a contact using the information on the custody and control form as your first point of departure. So let's go through the process. DOT is very specific about saying that you must document having made three attempts spaced over 24 hours. So clearly the idea that an MRO office is only going to be an 8 to 5 operation is out of the boards. Because people work evening shifts, people work night shifts, and if you only call at the same time of day every day, you're likely to never get a hold of the donor. So we need to space our attempts to reach the donor over a 24-hour period. Now you may contact the donor and arrange for them to then talk with your doctor but the actual interview must be done by the MRO. A few years ago, MRO assistants were doing a lot of the contacting of people, telling them their results were positive, asking them for information about prescriptions, etc. and the Department of Transportation came out very strongly and very clearly and said that is not acceptable. You can get the person on the phone but telling them the result and talking about their medication, that has to be done by the MRO. So let's say you've made your three attempts over 24 hours and you can't get a hold of the person. Then what do you do? Well, you know the answer. You then go for help and you contact your designated employer representative. They may have extra phone numbers. They may have emergency contacts. So the DER's job is then to do the same thing, to again make three attempts over 24 hours to get a hold of the donor and if they reach the donor, if they reach, let's say, Joe Schmedlap, they will say, Joe, I'm calling from your employer. There's a doctor that you need to talk with about a test result and you need to get a hold of that doctor within 72 hours. If you don't get a hold of the doctor within 72 hours, bad things may happen to you. So the DER is not supposed to know that this is a positive. So you're calling up your contact and you're saying, hey, I need your help. I need to talk with Joe Schmedlap and the person will say, oh, you got a positive? Well, you can't say, yeah. You have to say, well, I can't tell you why I need to talk with him, but you are my designated employer representative so you can probably figure it out. So you develop a sort of a relationship with the person where you don't divulge information, but obviously they know you're calling because there's a reason that you need to talk with that person. So if they reach the employee, then they need to let you know because that starts the three-day clock. After the employee has been notified to get a hold of you, then the 72-hour clock starts to run. If they're not able to get a hold of you, then, again, they need to let you know because then there's a 10-day clock. So, again, let's look at this. There's a three-day rule, which means three days after the DER has contacted the donor and told them personally to call you, if they haven't called you, then your office can go ahead and report that as a positive or a substituted or adulterated or whatever it is. If nobody can get a hold of the donor, and this is more likely to happen on an employment situation. I'm applying for a job. I do a drug test. Suddenly I'm getting a call from a doctor about test results. I figure I'm not going to get that job, so why do I bother to call? And that's a very frequent scenario for somebody who just never calls back. But after 10 days, what do we do with these folders that are piling up and piling up? I used to call them stragglers. Well, what we do after 10 days is to go ahead and verify them as whatever the laboratory said they were, and so that pile can then go down to a small level. And it's important to write all of this down, to use a very clear written set of sheets that you've developed in your office to document your attempts to contact the person when you left a message, what you said, and if you reached the person, that you actually talked with the person. Obviously, if you talk with somebody's spouse or their child, does that represent a contact? Not really. I mean, we've all gotten into trouble for giving a message to one person in the family and assuming that they're going to tell their spouse, and the spouse never heard. I mean, we all make that mistake. We don't make it more than once. So rule number one, we need to document in writing what we do because months later, when there's an administrative hearing or someone has challenged our positive drug test, we need to have in writing exactly what happened and our standard operating protocols that we can say that we routinely follow. So let's say we do get a hold of the person. So we've got a non-negative. You have reached the person, and now it's time to transfer that person to your MRO. The MRO needs to have a punch list, a standard checklist that they can go through in their interview. You have your punch list for your first preliminary discussion. The MRO also has a checklist, and I've included one that's fairly rigorous in tab 6, and you are welcome to use that, modify it in any form that you want. So the interview begins with the MRO identifying themselves. Hello, I'm Dr. Kent Peterson, and I'm calling you as the medical review officer for the XYZ Corporation. So my affiliation is with the employer. I want to make sure I've got the right Joe Jones on the phone. I have your Social Security, and the first five digits of that are 1, 2, 3, 4, 5. Can you give me the last four digits of your Social? And the person will say 6, 7, 8, 9. There's nothing more embarrassing than telling somebody that they have a positive drug test result, and then the person says, well, I think you need to talk to Joe Jones, Jr. I'm Joe Jones, Sr., and I didn't recently have any tests. So it's really important to make sure you've got the right person, even if they have the same name. So you tell the person who you are. You again reconfirm the identity of the donor, and then, and this is optional, you can inquire about the collection procedure. So you recently had a medical evaluation, and as part of that you gave a specimen of urine, and I have the results of that, and I have a statement that you signed at the time of the collection. How did that collection process go? Now, if you ask somebody how did it go, you're likely to be inviting trouble, because you weren't there. There's no video of it. They can tell you it was completely screwed up, and what can you do? All you know is that there's a statement that you have that says, this was my urine. It was collected, signed, and sealed in my presence, and I have not tampered with it. On the other hand, every MRO has talked with a donor who really described collection processes that really sounded very fouled up. So I have on occasion talked with a collector, challenged what they were doing, particularly when they were pouring urine from two collections into one bottle, you know, the first void and the second void, and I've had collectors tell me that they were doing things wrong, and I have canceled results, because I didn't believe that there was integrity in the process. So it is entirely optional whether the MRO talks about the collection procedures or not. I find that when I've talked to somebody and they've said, yep, I gave a specimen, everything was fine, then when I tell them it's positive, they're not going to all of a sudden start telling me how bad things were. We've already been through that, because I've said, so you gave a specimen, I've got the results, I want to go through them with you. The next thing that I need to do as an MRO is to read them their rights. There's no formal definition of Miranda, but if you recall, Miranda was a famous Supreme Court case in which a person had not been read their rights. And what are their rights? Remember your TV programs. You have the right to remain silent. Anything you say may be used against you. You have the right to an attorney. Now, those are sort of the standard TV words. But there is, in fact, a medical Miranda, and before we collect information about a person's medical condition, drugs that they're taking, information that's of a personal and confidential nature, we do need to let them know what might be done with that information, particularly if I have a duty to tell the employers about a safety issue in the workplace. And then after that, after you've read the person their rights, then you tell them the result. So let me read to you words from a medical Miranda that come straight out of the Department of Transportation language. The reason I'm speaking to you personally is to discuss the results of your drug test. There are a few things that are important for you to know. Number one, if any further medical evaluation is needed, you must comply with this request, and if you fail to do so, it's the same as refusing to discuss the test results. So in other words, if I'm going to ask you to have an opiate exam because you had positive for opiates, or ask you to have any further medical evaluation, if you don't do that, you're giving up your rights, and there are going to be some adverse consequences. Secondly, I am required to report to third parties without your consent drug test results or medical information affecting performance of safety-sensitive duties. So if you tell me that you're a truck driver taking methadone, or a truck driver who has epilepsy and is taking medication for epilepsy, I may be concerned that you really shouldn't have a driver's license, a DOT driver's license, and I have a duty to let those people know that. So I'm telling them before they give me information the consequences of their sharing that with me. So then I say, do you have the option of not discussing the matter with me if you choose? Do you have any questions at this point? So that's the formal DOT version of reading them the Miranda Rights. Then we go into the results. The results of your drug test have been received, and it is a positive. That was 10 seconds. It's amazing what a pregnant pause does in the MRO interview when you tell somebody their drug test was positive. That's the moment that the MRO is poised with their pen, ready to write down what the person says, and it's probably going to start with O, and the next word is probably going to be four letters. But it's amazing what people say. They got me. She guaranteed it was a negative. Which one was it for, Doc? People make amazing statements. So I allow there to be some silence, and I write down what the person says because the next few minutes are going to be very important. This may be the few minutes where somebody realizes they're not going to get the job, but it may be the moment when they realize they might really have a serious problem, and they really should see the substance abuse professional and find out if they have a problem and if it needs to be treated. So I tell them what it is, and then I wait, and then I explain the purpose of the interview. The purpose of this interview is to provide you with an opportunity to voluntarily share information with me. So I've read them the rights, and then they voluntarily share information with me that might explain this result, such as anything from your medical history, prescriptions that you're taking, recent treatment, something in your diet. Based on this information, I can make the best final determination of the result. So you're saying to the person as an MRO, you have a positive test. I'm here to actually give you an opportunity to explain it, because if you can give me a legitimate medical explanation and document that, then your positive drug test from the laboratory could be verified as a negative in terms of workplace drug testing. So this is, I like being an MRO because I feel that I can help people if they have a drug problem, I can help move them in to recognize the problem, and if they don't, I can save them their job because if there weren't an MRO, the employer with a positive result might very well can them. So I inform them of the result, I explain the verification process, and then I personally choose to ask them about using illicit drugs. Now if you say, so tell me about this illegal use of marijuana, you can imagine the person's gonna probably be pushing me back. But I can ask a different question, I can say, when's the last time that you used marijuana? Now that's a different question, and there aren't a lot of people who will say, I never used marijuana. Somebody may say, well, that was a really long time ago, Doc. Well, has it been in the last month or two? I don't think so. Have you been around anybody who was smoking marijuana recently? Well, yeah, come to think of it, maybe I was. Well, did maybe you just take a little toot off that joint? Well, now that you mention it, Doc. So I have found that in my discussions as an MRO, I feel better if the person really tells me what was going on. And the way that I approach that person very often engenders them speaking the truth. Because I'm not gonna hurt them by anything they say. And it's possible that I can help them. So I'll ask them if they've used the drug, and I've had situations where people said, I absolutely have no earthly explanation, this is impossible. And they go into telling me about their diet and their food supplements and all sorts of things. And so there are genuine mysteries in the process of explaining this. I will also often ask them about prescriptions and over-the-counter drugs. There's long lists of drugs that your MROs need to have handy and need to know which drugs can cause which positive drug results. And those are things that an MRO really has to be very familiar with. And I've put some checklists in the back of tab six to help you understand this process. But it's amazing how people will say when they're confronted with a positive result, I just don't have a clue. I didn't do anything, I didn't see anything, I didn't hear anything. They're basically numb. You know, they've just been caught and they're numb. And then you begin to have a friendly conversation and people usually are very forthcoming. It's important that the MRO offer a split sample. If this was a collection where there was a split specimen collected, the MRO needs to offer the split specimen. And again, the way that the MRO does it has a lot to do with it. If you say, you know, I need to tell you that there is another bottle that was collected and if you're willing to pay $100, it could be tested. But I have to tell you, I've never seen one that came back any different. You're gonna get one result. If you say, well, there's one way you could beat this rap. You know, there was a bottle B collected and sometimes it doesn't get to the lab. Sometimes it gets lost. And if you want that to be tested, you know, I can't force you to pay the money up front. And if it's not there or if the level's gone down a little bit, maybe it'll come back with a different result. Then people are likely to say yes. So the MRO has a lot of sway with people who are impressionable about whether they test it or not. I sometimes find that the person in the first interview is numb and they just don't, they can't make a decision. And yet eight hours later, they'll call me back having talked with their friends, their buddies, their union rep going online. And then they'll not only say, yes, I want that split to be tested, but they'll say, I wanna test it at this particular laboratory. And they do have the right to pick the certified laboratory but it has to be a SAMHSA certified laboratory. But it's amazing how quickly people, the donor who has been caught with a positive test will quickly educate themselves and tell you what they want. And then we need to answer technical questions. And there are many of these that come up. So let's go through step-by-step the different tests that can be positive and then we'll go through the other non-negatives. So the basic rule of thumb is that for every test that's positive with the one exception of opiates below the level of 15,000, the burden of proof is on the donor to provide a legitimate medical explanation. So if they can't provide a prescription, a doctor's note, a pharmacy verification, then that positive is gonna get verified as a positive. If the drug was obtained in another country, that represents a quandary. If I was in another country and I took it there and I just got back, then that's probably not a problem. Maybe I brought five days' supply back with me and I'm just finishing out my five-day supply. That will certainly influence the MRO. But if I like those little brown pills that come from Mexico and I'm now ordering them by mail order and it's been four years and I'm still getting those pills and they sure do make me feel good, that's obviously a different story. So this is, again, one of the areas of judgment, the judgment of the medical review officer, was there a legitimate medical reason? Now, if the donor says, yeah, I've got a prescription, there are two ways to go about it. You can say, well, give me the doctor's name and office number and we'll call. If you do that, what are you likely to encounter? You're likely to encounter a doctor's office that wants a HIPAA authorization. Before they're gonna release information, they want a signed statement by the donor. Well, the donor wasn't with you when you did your interview. So what I do is to tell the donor, I'm gonna give you five days to contact your doctor or your pharmacy, sign whatever forms your doctor wants you to sign, and then have them fax to me at this fax number the documentation. So I give them five days, five business days or five days of the calendar. It depends on the case. But I will generally give them five business days. But if it hasn't, if it, let's say it comes in, then what do I do? Well, sometimes we have a concern about an individual, a sixth sense, you could call it, and we will call up the pharmacy. We will call up the doctor's office and we will re-verify it and we've had people who falsified those documents. So that again is a matter of policy within your office. Another problem area is internet prescriptions. It's easy to go online, to fill out a questionnaire, and to get controlled substances over the internet. You pay a high price for that, but when you test positive and now you wanna call up and get a doctor's note saying that it was an authorized prescription, a lot of people are just fresh out of luck. I've seen some very sad situations where a donor could not get anyone to vouch for them. And as a result, I had to report it as a positive. Although I might've said this person had an internet prescription, they've sent to me the information about the prescription, but I don't have a pharmacist or a doctor's verification. So I'm reporting it as a positive. So if there is a legitimate documented medical explanation, I'm gonna call a laboratory confirmed positive. I'm gonna verify it as a negative. Now that causes people initially some concern. Why can you call it a negative if it's a positive drug test? And I'm not saying it's a negative drug test. I'm saying it's a negative in terms of them violating the workplace policies about using unauthorized substances. So a negative means they did not use unauthorized substances and I always have the safety concern that I can also report. I can say it's a negative, but I have some concerns about a condition that they have, treatment that they're taking, about safety in the workplace and I'm gonna suggest that they have a further medical evaluation. I always can pull that trump card if I have some uncertainty about safety in the workplace. So in terms of positives, fencyclidine. There is no legitimate medical explanation for PCP. There's no legitimate medical explanation for taking ecstasy or one of the similar drugs that are synthetic methamphetamines. So why do we communicate with the donor? Well, one reason is because we need to tell somebody what's gonna happen. You had a positive drug test. I need to let you know that. I'm a doctor. I've reviewed it. There's no legitimate explanation. You are going to be given by your employer a list of names of substance abuse professionals. I would encourage you to talk with one of these people, even if it's at your own expense and see if you have a real drug problem. If you do, this could be the wake-up call that could change your life. It's really important to tell people what's coming and it's also required under the federal program. Marijuana. There is one legitimate explanation for a positive THC and that is the prescription, the Schedule III drug of dronabinol or marinol. There's another version in Canada and that is considered an authorized medical use. Now, medical marijuana is not acceptable for federal employees. Whether you consider that, whether your MRO considers that acceptable depends upon where you are, the employer policy because you're acting under the guidance of the employer policy and it also depends to some extent on your MRO's attitude. But you know what the federal stance on that is. Cocaine. There are certainly many medical, medical uses of cocaine. Ear, nose and throat uses it to shrink the nasal mucosa, to be able to see into the sinuses, to be able to check for nasal polyps or even to do bronchoscopy or other surgery of going deeper in the respiratory tree. Ophthalmologists will use it to swab or dab on the eyes or inject in the eyes because it shrinks, it's a vasoconstrictor and it takes away the bleeding and allows for a better surgical operative field. Emergency rooms. There's a product called TAC, tetracaine adrenaline and cocaine which is swabbed on a cut, shrinks the blood vessels, reduces the bleeding and allows proper bandaging and treatment or suturing. And surgery, various surgical procedures. So cocaine is a very powerful and useful drug and it of course is a drug of abuse. So sometimes you have to get the medical records and read through them fairly carefully to find the use of cocaine. The fourth class is the amphetamines. So are amphetamines legitimately prescribed? Yes, many doctors prescribe amphetamines for many reasons. Years ago they were taken as a common weight loss drug that has been highly discouraged now of doctors but there are other drugs that contain amphetamines and are very useful. One example is for people with ADHD who take Adderall and people who have attention deficit disorder will take Adderall. I've had truck drivers who regularly took Adderall. They were positive but they'd been taking it for years. Their doctor said it did not cause a workplace safety concern and so those became negatives. Same thing with methamphetamine. The thing that you need to know and your MRO will know this for methamphetamines is that there's two forms. There's a D and an L isomer. There's a molecule and the meth is added to amphetamine. So you have amphetamine in the center and then a methyl group stuck either on the right or the left and that's either a dextro or a levo, D and L and the illegal drugs are usually D form and the legal drugs are usually L's. It's interesting, L stands for legal and D stands for drug. So asking the laboratory to do a DL separation helps to distinguish between the use of a legitimate medical drug and an illicit drug. So I recommend to employers that they routinely have the laboratory do a DL separation for every positive methamphetamine. That way when you, the MRO office, get the results you already have or have coming the DL separation. That speeds things up a great deal and it's also a lot cheaper. So MROs learn a lot about distinguishing between D and L and mixtures of D and L and what's called the 80-20 rule. Opiates, we've already talked about that the opiates that can be found in the federal program are for heroin, morphine and codeine. There's also a test now routinely done by the laboratory for 6-monoacetylmorphine which is a natural breakdown product of heroin. So there are legitimate reasons for people taking morphine for pain, many legitimate reasons for taking codeine for pain. There are no legitimate reasons for taking heroin for pain. So a 6-AM means a person has been using heroin and that's most likely going to result in a positive test. So with regard to verifying opiate positives, if there's a 6-AM there is no acceptable medical explanation. However, the MRO now must also contact the laboratory and if there's a 6-AM make sure that morphine was present because heroin degrades to 6-AM and then it degrades to morphine. If there's a morphine or a codeine above 15,000 then the donor has to document a prescription or medical explanation. The one gray area is with the morphine and codeine between 2000 which is the low end of the cutoff and 15,000. And the reason for the concern in this area is because eating large amounts of poppy seeds can explain a result up to as high as 14,000. 14,999. Poppy seeds will never go above 15,000 but they can be up into the 12 and 13,000. So for that reason the federal regulations say a morphine or a codeine in that range by itself is not going to be a positive. You also have to have independent clinical evidence either obtained from a medical examination or from a medical history, from the person telling you yes I did take codeine or yes I took my spouse's codeine in the middle of the night for a severe headache. So if they tell you they took it that's considered medical information, that's clinical evidence. What do you do about somebody who says I took my spouse's drug? Well the federal regulations are now silent about that issue so this is another area of judgment on the part of the MRO. The DOT earlier gave guidance saying it is not authorized use for you to be taking your spouse's medication. You may have compassion and understand it if it's true but it's not authorized use and I as an MRO have gone so far as to say to somebody okay you took your spouse's medication and you told me that, I'll tell you what, I'll make a deal with you. You have your spouse's doctor write me a note saying that they authorize you to use that medication for one time on that date and then I will accept that as my documentation and I've actually had doctors that did that. So this is one of those gray areas that has come up. Now if they tell you well I'm taking six other drugs, you know I'm taking Oxycontin and Percocet and that's why I had a high codeine, does that explain the codeine above 15,000? No, but then you're learning that they're taking other drugs and if you have a concern about safety then that'll be a different call by the MRO. So opiates and amphetamines are the two areas where there can sometimes be issues. So here's my summary of everything I know about opiates. An MRO calls it a positive if they're not able to contact the donor under the three day or the 10 day rule. They'll call it a positive if the donor refuses to talk to the MRO. They've given up their right to provide an explanation. I'll call it a positive if there's a positive six acetylmorphine because that really indicates the use of heroin as long as there was some morphine present in the urine. And if it's more than 15,000 and there was no documentation, that'll be another positive. Otherwise I'll call it positive if it's below 15,000 and there's independent clinical evidence of unauthorized use such as somebody telling me they took it or finding needle tracks or signs of opiate abuse on a clinical exam. And the negatives then are above 15,000 and there was a documented use or below 15,000 but there's no evidence. So I call someone up, I say you've got a morphine level of 14,000. Any idea what's causing that high level? They say, gosh, doc, I don't know what morphine is. Well, have you been taking a lot of poppy seeds? I don't know what a poppy seed is. Have you been using somebody else's medication? Not that I can recall. I just can't help you, doc. You're stuck. This is gonna be a negative unless you have that person get an exam and there's clinical evidence of drug use, unauthorized drug use. So as Dr. Pete just said in his slide, sometimes the dragon wins. And this is an example where as MROs we're sometimes troubled by what we find. But I think the rules are basically sound. They make sense. And for me, they have worked well. Now the doctor needs to know which drugs, which prescription and non-prescription drugs can cause a confirmed positive test. So there are in your syllabus two different lists. And one is from a memo from the Department of Health and Human Services some years ago. And the other is an appendix from the book, MRO Manual written by Dr. Switinsky and Dr. Smith. And these are very comprehensive lists of drugs that can cause positives. And I think it's really helpful for MROs to know this. Now let's move from positives to adulterateds. You know, what is an adulterated specimen? We sort of know it, but it's helpful to have the definition. You know, it's a specimen that contains a substance that shouldn't be present in urine, like glutaraldehyde or chromium or some of the halogens or a substance that's expected to be there like nitrites, but not above 500 micrograms. So it's too high. That is what is adulterated. So obviously somebody put something in that urine. Now for a laboratory to report it as adulterated, they have to not only think that there's an adulterant, but they have to test it by two independent methods and measure and confirm the adulterant. So they have to say it was too acidic or too basic. The pH was too low or too high. There was glutaraldehyde or chromium or peroxide or something like that. And they have to confirm that by two different methods. If they can't confirm it, then they're gonna call it not an adulterated specimen, but there's gonna be a different name for it, which we're coming to. And they have to do quantitative tests on both nitrites and the pH. So those are the two areas where the laboratory has to give you measured results. A substituted specimen means somebody didn't put something in the urine, but they obviously took away human urine and they substituted something else which was so highly dilute that it does not contain what we normally find in human urine. Specifically, it does not have enough solutes to have a high specific gravity. So it is at 1.0010 or less. So it's so dilute or it's so concentrated that it's at 1020 or above. And in addition to be substituted, it also has to have a creatinine level below two. So I think of it as you have to have two criteria, both of them met to be a substituted specimen. If you don't have them both, then you won't call it a substituted specimen. And if it's substituted and you tell the person you have evidence of substituting your specimen for urine, you still have to treat it the same way you do a positive. You've got to offer the donor an interview. You've got to explain the laboratory findings. You've got to answer technical questions. You've got to offer a split specimen analysis to the donor. You've even got to offer the donor the opportunity to present a legitimate medical explanation for why they can have pyridine in their urine or why they can have such a highly dilute urine. And so we're always leaving open the possibility of a rare medical condition that could explain it. But the burden of proof is on the donor. They've got to go find a doctor who can provide medical evidence. They've got to pay for those evaluations, and they have to do it in a very quick time frame. So they have to give you this information at the time of the initial interview or within five days, or otherwise you're going to call it an adulterated or substituted specimen. If they do have what sounds like a plausible story, then you may be asked to help your MRO, get them an appointment with a nephrologist to check on kidney disease, to help them explain their rare and unusual condition. Now I've been holding off what happens if only one of the two criteria of substituted are met. If you have both of the criteria, dilute and no creatinine, it's substituted. If only one of those criteria is met, but not both, then the lab will report it to you as an invalid specimen. That means we couldn't do a test. We think something's going on, but we can't explain it. Maybe they suspect an adulterant. They found a low level of it, but not a high enough level. Or they suspected it, but they didn't take the time and pay the money to do a second form of quantitative analysis. So they then say it has an unidentified substance with abnormal physical characteristics, which keeps us from completing our test. So what does an MRO do with an invalid specimen? Well, the thing I think about is an invalid specimen always leads to two phone calls. First, the MRO calls the laboratory certifying scientist and says, hey, tell me what's going on here. What did you find? What do you suspect? What do you recommend we do? So a call to the certifying scientist is really useful. It also encourages labs to do more of the analyses so they don't get so many phone calls. The other phone call is to the donor, saying to the donor, something interfered with the lab's ability to test your urine. What's going on here? Are you taking some medication that could be interfering with the laboratory equipment? And in fact, certain medications can interfere with laboratory testing, particularly with the immunoassay. Now, I've mentioned three drugs, and I've given their actual brand and generic names, but these are examples, one of a nonsteroidal anti-inflammatory, another is an antibiotic, acipro, and a third is an anti-parasite, anti-helminthic drug, flagyl. So in this case, when the lab was unable to verify there's two things that happen. One, you do not offer a split specimen, because if you couldn't analyze the first specimen, what makes you think you could analyze the second? And the second thing is you're always going to cancel an invalid specimen. It'll always be reported as canceled, but there's two ways to cancel it. One is with an explanation. This person had an invalid test, because they're taking certain medication, which interfered with the drug, and I'm giving that a medical explanation, no further action is needed. The other kind of cancellation says, there's no explanation. We don't know what's going on, so we're directing you, employer, to do an immediate recollection of another specimen under direct witness observation. So those are the two results of an invalid specimen. You're always going to cancel it, but the consequences are different. One goes back into the random pool, and more intensive evaluation as to whether somebody was tampering with the urine. Now what happens if you get a repeat invalid? It was invalid the first time, so now you collect a second specimen, under direct observation. Well, if the second specimen wasn't directly observed, that's a non-test. You've got to send them back for a third collection. But if they did properly collect the second specimen, and it comes back as invalid for the same reason, then you're not going to do it a third time. If something is really funny going on, messing up the analysis, you're not going to subject this person over and over again to more collections. But if the second one is invalid for a different reason, then you would go on to do a third collection. So here's where you need to be fairly up on the recent DOT regs that were released in 2010. Now we have another complex situation where you have multiple specimens from a single test event. Let's say the person started to give a urine, and there was evidence of tampering. So the collector took that bottle, labeled it. Maybe there wasn't enough for a split. Remember what Donna said, but said, this was specimen 1 of 2, evidence of tampering. You know, it was frothing, or it smelled funny. Then you'll do a second directly observed collection, and send that in on a different custody and control form saying specimen 2 of 2. Send them both to the lab, and then you'll have a second test so that's the way they're labeled. They come back to you, specimen 1 of 2, specimen 2 of 2. But they're both treated as a single reporting event. So if either one comes back positive, that's enough for a positive. They don't both have to be positive. I've actually had the first one that was tampered with come back negative, and the second one, even though it was more dilute from drinking water, come back positive. I've also had the opposite. The first one ended up being negative and the second one was positive. So if either one is positive, that's treated as a positive. The same thing if either one is adulterated or substituted, then that's all you need. If the first one is negative, in this case, I would not report it to the employer as negative, but I'd wait to get the second. But if the first one is non-negative, if it's a positive, then I would go ahead and report it right away, and then I'd wait for the second one. I can always cancel it later, but I want to get that information to the employer as soon as possible. Now, another somewhat complicated situation is you have multiple results on a single specimen. So once it's been verified by an MRO, you should report it immediately. If the donor wants a split specimen, sure, the split specimen can be analyzed at another laboratory, but don't wait to report the first specimen because safety is a concern at this point. And then if the split comes back, failure to reconfirm, you can always change the result. There is no moral penalty, no legal penalty for saying, I called it a positive, but now the second specimen has come back negative, and I'm canceling both of them. Better to report it and then to change it than to wait. Now, we can sometimes have dilute specimens. If it's positive and it's also dilute, DOT says we should report the dilute as well as the positive. As an MRO, as far as I'm concerned, it's positive, but it's good to also include that it was dilute. What about a negative dilute? This is a little bit more complicated. It's a little bit more complicated than a negative dilute. It's a little more complicated because we have two forms of negative dilute. We have what I call extremely dilute or highly dilute where the creatinine was between 2 and 5. Now, that's getting down to the level of impossible, getting down close to the level of incompatible with human life. So if you have a negative that's dilute and the creatinine is reported to you by the lab as 2 to 5, you do not need to call the donor. You can immediately call the employer and say, we need to get another witness collection right away because that's a highly suspicious urine. Now, the other, if the creatinine is above 5 and less than 20, then it's reported as a negative dilute, and at that point, the employer has an option. They can do another collection, not a witness collection, but another collection. If they don't like dilute urines, they can do one more collection, or they can accept it, but if they do another collection on one person, they have to be uniform and treat everybody the same way. So here's where it's important, again, to know your employer's policies. So you get the result. Your MRO has made the verification decision. You've provided all the support you can to help collect the information, and this is the information about reporting. You know, you must review copy 2, the MRO copy. As Donna said, you've got to have received from the collection site a copy of that before you can report a positive to the employer. Negatives, you can transmit them electronically, but non-negatives have to have an MRO signature. So a negative, you can stamp the MRO's name. That's okay, but a positive or a non-negative, the MRO, him or herself, has to sign that communication that goes to the employer. So within the same business day, you call your DER and say, I've got a substituted or an adulterated, which is, of course, a refusal to test, but then within two days, you send a written confirmation report to the employer. And here's the information that has to be on the result. You don't have to send them copy 2 of the custom control form. I use my own reporting form, but this is the information that has to be on that communication that goes to the employer. So this is a summary chart. I'm not going to walk through it, but this is useful for you to review. On the left, what comes in from the laboratory, and on the right, all the different possible reports. So it goes on for two pages. And as far as split specimens, there's one secret thing to learn about split specimens. A split specimen will never come back to you and say positive for cocaine. It'll come back and it'll either say reconfirmed or failure to reconfirm. So it doesn't come back positive. It basically says we confirmed, we reconfirmed, because levels often drop while they're in the specimen containers. They're just looking for the presence of that drug to make sure that it was there the first time. So you don't have the same standard for positives. But on the other hand, for adulteration and substitution, you've got to meet the same technical standards. So this is information on the splits and on the way that you treat the laboratory and the report. So canceled tests. I made a summary of all the reasons why you have to cancel a test. And they're listed in this slide. I won't read them for you, but remember, only the MRO can cancel a test. And these are examples of canceled tests. Can you change a result once you send it to the employer? Sure, because sometimes you get new information. You know, you can reopen a case if you couldn't get a hold of a donor. They never called you back. And then two weeks later, they call you back and say, I just got back in the country. Just got your message. Sure, I'm taking prescription meds. Here's my verification. You've already reported it as a positive. You can go back and call it a negative. You can reopen a case if there's a legitimate reason. Now, if it goes beyond 60 days, then D.O.T., then HHS, actually D.O.T. wants to hear about it personally and get involved in the case. Record keeping. Negatives, the records have to be kept by the employer and by you for one year. For the non-negatives, five years. You keep all your documentation then, all your check sheets, all your worksheets. Now, if somebody says, well, I'm an employer and I want to have everything transferred to another MRO, you don't have to keep a thing. You can box up everything and ship it over to another MRO and you're not going to be responsible for keeping extra copies of everything forever. So that's good news. And another last point, a critical point. D.O.T.'s legal counsel has strongly urged that drug test results be kept separate from a patient's medical chart. A patient's medical chart is doctor-patient relationship. If somebody says, I want copies of my records or I want you to send those records to a new doctor, those things have to be done. However, if it's a drug test, there's a higher standard that has to apply. So in that case, you should keep those separate. Now, I mentioned earlier confidentiality. There are certain situations under which you will be required to report information to an employer or to a third party. And here they are. If what you've learned means that they're likely to result in a disqualification, let's say they're a truck driver and they have a medical condition that they should not be a truck driver and have, or they're taking certain medication. So that would be examples of disqualification. Or if they're taking drugs that you believe really are incompatible with working in safety-sensitive jobs, then the second one pertains. Continued performance of the employer's safety-sensitive function likely poses a significant safety threat. You'll notice that wording is very carefully worded, probably written by an attorney. But those are the circumstances where you not only may but must report to the employer. Now, I do not give the specific information to the employer. I do not list the medical conditions. I do not give them the names of the drugs. What I say is, I have a safety concern. I'm recommending that you have this person have a clinical evaluation by a doctor who can evaluate your employee's fitness for duty. And I will talk with the examining physician. I will provide all that information directly to that person doctor to doctor. But I don't disclose that information to the employer. In wrapping up this segment, let's talk about the differences between federally regulated testing and non-federally regulated testing. And the biggest single difference is the panel of drugs that's being tested for. Federal tests, five classes of drugs. Broader panels, eight, 10, 12. If we're talking about impaired physicians and nurses, we may be testing for 50 different substances. Probably not all on the same day, but there may be a 20-panel test and a 15-panel test, and we'll rotate them. So depending upon the employer, the problems in the industry and the area, and what they feel are the important issues, the panel of drugs being tested for may be different. Another difference, the custody and control form. There's a federal regulated custody and control form, and then there's a non-federal form, and so there's some differences. One of the differences is that some of the employers will actually ask the donor to write the list of medications that they're taking at the time that they give their specimen. That's not allowed under DOT, but it is by other people. Donna talked about the person who comes to the collection site carrying their bag of pills. Well, sometimes those get written down in a non-federal situation. Witness collection. The military program, 100% of urines that are collected are under direct observation. Certain other industries, there will be a collection under direct observation, so that depends upon the employer. Cut-off levels. Cut-off levels have just changed. Well, they may not change for some of the testing programs, but they just did for the federal testing program. A lot of programs do not use split specimens. If you asked most of us as MROs, have you really seen situations where a split specimen changed the outcome? Do you really think it's worth the time and trouble? Most of us would say no. It may give assurance to the donor, but it really doesn't make a difference. So there are many testing programs where there is no split specimen. If there's a question about retesting a urine, a different aliquot of bottle A will be tested again. Maybe even could be sent to a different lab, but you don't have to have two bottles. On-site testing. You've heard that word? That is also called point-of-collection testing, where a person provides a urine specimen, and it's tested right then and there with the simple test kit. If it's positive, the person does not go to work. But the specimen is then sent off to a laboratory for a confirmation testing. So it's a screening test. It's an initial test, but if it's sensitive enough, it will keep the person out of work until the laboratory does the heavy lifting. So that's often called point-of-collection because the testing is done at the place of collection. So it's also called on-site. That's another difference. Many employers want to have the results right away. And then, of course, there's hair. You're doing hair testing in your facility for one client. There's blood testing, although there are issues with blood, and certainly oral fluids. And oral fluids is getting increasingly sophisticated, and I think that the federal government is moving quickly in the direction of authorizing oral fluid testing for federal employees. There are differences in the MRO role. You may be interpreting the results of a broader panel. You may have to get involved in hair testing and reviewing as an MRO the results of hair testing. You're certainly going to get involved in the non-federal segment in interpreting medical marijuana, and it depends on the employer's policy. MROs can sometimes choose to serve as a substance abuse professional and get trained and certified as an SAP as well as an MRO. Some cases, employers will ask you to do the fitness for duty exam or to do the return to work determination. It's not always have to be done by an SAP. You can do those yourselves. Many MROs are asked to help interpret breath alcohol testing results. It's not required under DOT, but certainly many MROs do that. And finally, developing the follow-up testing program after a person's been through rehabilitation. That is often done by the MRO. So those are some of the broader roles that MROs play. So as we come to the end of this segment, I would suggest that an MRO firm needs to talk with their company to know their policies, to establish how is the employer going to handle dilutes. Are they going to automatically have all the negative dilutes retested? Who's going to pay for the split specimens? What do we tell the people about the payment for splits? Do you routinely get a D and an L isomer separation for methamphetamines? Is there a policy with regard to the use of spousal medication? How about a policy for the use of foreign drugs? Do they have an SAP? Do they pay for rehabilitation? What do you do if somebody shows up at a collection site and they have .02 alcohol on their breath? That's the equivalent of one drink on board. Do you send them off in their car? Or do you pay for a cab and have them leave their keys? Or do you call the workplace and have someone else drive them home? That's really important to talk with your employer about and establish before the situation actually arises. Do they pay for treatment? Do they give people one opportunity for treatment? Two opportunities? Those are the kinds of things that are important. And who's submitting the blind quality controls? If it's a large employer with lots of drug tests, they have to submit blinds so you may be able to help them there. So all of these are issues that you need as an organization, as an enterprise. You need to know the MRO assistant to be able to deal with. So it's not an easy job being an MRO or an MRO assistant. You have very interesting conversations with people. You get involved with labs, with collectors, with SAPs, with employers. And the most interesting conversations are always with the donors. So that completes this segment of our program.

MRO assistant

drug test results

custody and control form

interviews with donors

reporting results

safety concerns

negative results

drug testing process

explanation for results

confidentiality